Aviceda Therapeutics announced that the U.S. Food and Drug Administration (FDA) has cleared the IND for AVD-104, enabling the company to proceed with initiating phase 2 clinical trials of its lead intravitreal ocular asset for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The phase 2 SIGLEC trial is expected to begin in Q2 2023.
“The FDA’s acceptance of our IND application to initiate the clinical evaluation of AVD-104 brings us one step closer to introducing a potentially paradigm-shifting treatment for people living with geographic atrophy and macular degeneration,” said Mohamed Genead, MD, Aviceda’s co-founder, president & CEO. “The AVD-104 IND clearance marks an important milestone for Aviceda as we continue our track record of execution as the leader in the glycome field. We are thrilled to advance the development of AVD-104 in the U.S. and are working to rapidly enroll patients in the phase 2 portion of the study. We look forward to presenting additional data later this year.”
AVD-104 is an intravitreal nanoparticle molecule with a unique dual mechanism of action for the treatment of GA through its modulation of critical inflammatory pathways via inhibition of the activity of retinal macrophages and repolarization of activated macrophages to their resolution state coupled with inhibition of complement cascade amplification.
“I am very excited to bring the power of our glyco-biology based technology platform to address the significant unmet medical needs in patients with macular degeneration. As a practicing vitreoretinal specialist, I saw firsthand the devastating effect of this disease on my patients. This is the first step in bringing a novel and differentiated therapy to these patients,” said David Callanan, MD, CMO of Aviceda.
About Aviceda Therapeutics and AVD-104
Aviceda is a private clinical-stage biotechnology company located in Cambridge, Massachusetts, with a proprietary nano-technology HALOS™ platform and an IND-cleared ophthalmic lead product for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
AVD-104 is an intravitreal nanoparticle molecule with a unique dual mechanism of action for the treatment of GA through its modulation of critical inflammatory pathways:
1) Direct inhibition of the activity of damaging phagocytic macrophages and repolarization of activated macrophages to their resolution state, and 2) Inhibition of complement cascade amplification.
AVD-104 has demonstrated robust in-vitro/vivo efficacy with inhibition of both inflammatory & complement pathways and the potential for every 4-6-month dosing.
Outstanding safety has been demonstrated in multiple animal models, including non-human primates, in which no signs of intra-ocular inflammation were seen. In addition, AVD-104 has demonstrated anti-neovascular activity equivalent to that of aflibercept (Eylea) in a well-established ocular CNV model. Phase 2 clinical trial is expected to begin in Q2 of 2023.
Along with AVD-104, Aviceda has a broad pipeline of products in development in ophthalmology and multiple other therapeutic areas including neurology, oncology, fibrosis, and immunology.